Eledon Pharmaceuticals Highlights Recent Business Milestones and Provides 2024 Outlook
04 Gennaio 2024 - 10:40PM
Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today
announced a summary of 2023 accomplishments and provided guidance
for anticipated upcoming 2024 milestones.
2023 Key Highlights
- Reported updated data from ongoing
Phase 1b trial evaluating tegoprubart for prevention of rejection
in kidney transplantation. Data from 11 trial participants
demonstrated that tegoprubart was generally safe and well-tolerated
in patients undergoing kidney transplantation, with aggregate mean
estimated glomerular filtration rate (eGFR) above 70 mL/min/1.73m2
at all reported time points after 90 days post-transplant. Amended
the Phase 1b trial protocol to add a second cohort, now allowing
enrollment of up to 24 trial participants who are undergoing kidney
transplantation.
- Dosed first participants in Phase 2
BESTOW trial assessing tegoprubart head-to-head with tacrolimus for
the prevention of rejection in kidney transplantation.
- Dosed tegoprubart in second-ever
transplant of genetically modified heart from a pig to a
human.
- Completed financing of up to $185
million, with $35 million in upfront funding and additional
aggregate financing of up to $105 million, subject to achieving
clinical development milestones, volume weighted share price
levels, and trading volume conditions, as well as up to an
additional $45 million upon exercise of warrants. If all
commitments are met, the financing is expected to be sufficient to
fund the Company through the completion of the Phase 2 BESTOW
trial, subject to the achievement of specified milestones,
including clinical development enrollment targets.
- Partnered with the University of
Chicago Transplantation Institute to secure financing from the
Juvenile Diabetes Research Foundation (JDRF) and The Cure Alliance
to fund an investigator sponsored study in pancreatic islet cell
transplantation in participants with type 1 diabetes. Tegoprubart
treatment will be evaluated for the prevention of transplant
rejection.
- Strengthened leadership team with
appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer
and strengthened board of directors with appointment of Allan Kirk,
M.D., Ph.D. and James Robinson.
“Eledon made significant progress in 2023 on multiple fronts,
highlighted by the presentation of the first clinical evidence of
tegoprubart’s potential to prevent organ rejection while producing
robust improvements in eGFR and maintaining a favorable safety
profile. We were also honored to play an important role in the
second-ever transplant of a genetically modified heart from a pig
to a human with the use of tegoprubart as part of the patient’s
cornerstone immunosuppressive regimen,” said David-Alexandre C.
Gros, M.D., Chief Executive Officer of Eledon. “In the coming year,
we look forward to building upon the promising results from our
tegoprubart kidney transplant Phase 1b trial, generating additional
long-term data from the Phase 1b extension study, and completing
enrollment in our Phase 2 BESTOW trial.”
Anticipated 2024 Milestones
- First half of 2024: Report updated
interim clinical data from the ongoing Phase 1b trial of
tegoprubart in kidney transplantation.
- First half of 2024: Dose the 12th
participant in the Phase 2 BESTOW trial. Upon the dosing of the
12th participant, the Company will have completed both clinical
development milestones related to the second financing tranche from
the private placement announced on May 1, 2023.
- End of 2024: Complete enrollment in
the Phase 2 BESTOW trial of tegoprubart in kidney
transplantation.
- 2024: Dose the first islet cell
transplant participant for the treatment of type 1 diabetes at the
University of Chicago Transplantation Institute.
About Eledon Pharmaceuticals and
tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage
biotechnology company that is developing immune-modulating
therapies for the management and treatment of life-threatening
conditions. The Company’s lead investigational product is
tegoprubart, an anti-CD40L antibody with high affinity for CD40
Ligand, a well-validated biological target within the
costimulatory CD40/CD40L cellular pathway. The central role of
CD40L signaling in both adaptive and innate immune cell
activation and function positions it as an attractive target
for non-lymphocyte depleting, immunomodulatory therapeutic
intervention. The Company is building upon a deep historical
knowledge of anti-CD40 Ligand biology to conduct preclinical and
clinical studies in kidney allograft transplantation,
xenotransplantation, and amyotrophic lateral sclerosis (ALS).
Eledon is headquartered in Irvine, California. For
more information, please visit the Company’s website
at www.eledon.com.
Follow Eledon Pharmaceuticals on social
media: LinkedIn; Twitter
Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. Any statements about
the company’s future expectations, plans and prospects, including
statements about planned clinical trials, the development of
product candidates, expected timing for initiation of future
clinical trials, expected timing for receipt of data from clinical
trials, the company’s capital resources and ability to finance
planned clinical trials, as well as other statements containing the
words “believes,” “anticipates,” “plans,” “expects,” “estimates,”
“intends,” “predicts,” “projects,” “targets,” “looks forward,”
“could,” “may,” and similar expressions, constitute forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are inherently
uncertain and are subject to numerous risks and uncertainties,
including: risks relating to the safety and efficacy of our drug
candidates; risks relating to clinical development timelines,
including interactions with regulators and clinical sides, as well
as patient enrollment; risks relating to costs of clinical trials
and the sufficiency of the company’s capital resources to fund
planned clinical trials; and risks associated with the impact of
the ongoing coronavirus pandemic. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various factors. These risks and uncertainties, as
well as other risks and uncertainties that could cause the
company’s actual results to differ significantly from the
forward-looking statements contained herein, are discussed in our
quarterly 10-Q, annual 10-K, and other filings with the U.S.
Securities and Exchange Commission, which can be found
at www.sec.gov. Any forward-looking statements contained in
this press release speak only as of the date hereof and not of any
future date, and the company expressly disclaims any intent to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor Contact:
Stephen JasperGilmartin Group(858) 525
2047stephen@gilmartinir.com
Media Contact:
Jenna UrbanBerry & Company Public Relations(212) 253
8881jurban@berrypr.com
Source: Eledon Pharmaceuticals
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